COVID-19: a meta-analysis of diagnostic test accuracy of commercial assays registered in Brazil

Rodolfo Castro, Paula M Luz, Mayumi D Wakimoto, Valdilea G Veloso, Beatriz Grinsztejn, Hugo Perazzo, Rodolfo Castro, Paula M Luz, Mayumi D Wakimoto, Valdilea G Veloso, Beatriz Grinsztejn, Hugo Perazzo

Abstract

The accuracy of commercially available tests for COVID-19 in Brazil remains unclear. We aimed to perform a meta-analysis to describe the accuracy of available tests to detect COVID-19 in Brazil. We searched at the Brazilian Health Regulatory Agency (ANVISA) online platform to describe the pooled sensitivity (Se), specificity (Sp), diagnostic odds ratio (DOR) and summary receiver operating characteristic curves (SROC) for detection of IgM/IgG antibodies and for tests using naso/oropharyngeal swabs in the random-effects models. We identified 16 tests registered, mostly rapid-tests. Pooled diagnostic accuracy measures [95%CI] were: (i) for IgM antibodies Se=82% [76-87]; Sp=97% [96-98]; DOR=168 [92-305] and SROC=0.98 [0.96-0.99]; (ii) for IgG antibodies Se=97% [90-99]; Sp=98% [97-99]; DOR=1994 [385-10334] and SROC=0.99 [0.98-1.00]; and (iii) for detection of SARS-CoV-2 by antigen or molecular assays in naso/oropharyngeal swabs Se=97% [85-99]; Sp=99% [77-100]; DOR=2649 [30-233056] and SROC=0.99 [0.98-1.00]. These tests can be helpful for emergency testing during the COVID-19 pandemic in Brazil. However, it is important to highlight the high rate of false negative results from tests which detect SARS-CoV-2 IgM antibodies in the initial course of the disease and the scarce evidence-based validation results published in Brazil. Future studies addressing the diagnostic performance of tests for COVID-19 in the Brazilian population are urgently needed.

Keywords: Coronavirus; Diagnostic accuracy; SARS-CoV-2.

Copyright © 2020 Sociedade Brasileira de Infectologia. Published by Elsevier España, S.L.U. All rights reserved.

Figures

Fig. 1
Fig. 1
Pooled diagnostic accuracy analysis (A) and summary receiver operating characteristic curve (B) of tests (n = 8) for detection of IgM antibodies tests against SARS-CoV-2.
Fig. 2
Fig. 2
Pooled diagnostic accuracy analysis (A) and summary receiver operating characteristic curve (B) of tests (n = 8) for detection of IgG antibodies tests against SARS-CoV-2.
Fig. 3
Fig. 3
Pooled diagnostic accuracy analysis (A) and summary receiver operating characteristic curve (B) of tests (n = 4) using nasopharyngeal and/or oropharyngeal swabs for detection of antigen or nuclei acid of SARS-CoV-2.

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Source: PubMed

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